Ostrea d.o.o.
⚠️ Moderate Risk
FEI: 3010643756 • Stankovci, Zadarska • CROATIA
FEI Number
3010643756
Location
Stankovci, Zadarska
Country
CROATIAAddress
Ulica Hrvatske Vlade 1, , Stankovci, Zadarska, Croatia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/21/2015 | 16AEE73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ostrea d.o.o.'s FDA import refusal history?
Ostrea d.o.o. (FEI: 3010643756) has 6 FDA import refusal record(s) in our database, spanning from 9/21/2015 to 9/21/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ostrea d.o.o.'s FEI number is 3010643756.
What types of violations has Ostrea d.o.o. received?
Ostrea d.o.o. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Ostrea d.o.o. come from?
All FDA import refusal data for Ostrea d.o.o. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.